Patent application title: Device For Covering a Syringe and Needle in Order to Alleviate the Fear and Anxiety Experienced During Pediatric Medical and Odontological Procedures, Such as the Administration of Anesthetics and the Like

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Abstract:

Device for covering a syringe and needle in order to alleviate the fear
and anxiety experienced during pediatric medical and odontological
procedures, such as the administration of anesthetics and the like. A
device for use, in particular, by a pediatric odontologist for
administering anesthetics, or by other health care professionals for
administering an injectable medicament, vaccines, collecting blood, etc.,
characterized by comprising a module for covering the syringe and needle
(1, 9a, 9b, 9c, 9d, 9e and 9f), and by a needle guide that prevents the
needle from breaking when an anesthetic (2) is injected, facilitating a
positive behavior in the pediatric patient being treated in the medical
or odontological clinic, and eliminating the fear, anxiety and discomfort
of such a patient during restoration and surgical procedures.

Claims:

1-4. (canceled)

5. A device for covering a syringe and a needle for overcoming fear and
anxiety in a pediatric medical or dental procedure during the
administration of anesthesia or other medicine comprising; a sleeve
module for covering the syringe and needle, according to any one of FIGS.
1, 9a, 9b, 9c, 9d, 9e and 9f; and, a guide for the needle that prevents
breakage of the needle during injection of the anesthesia or other
medicine.

6. The device of claim 5, the sleeve module comprising: dimensions of the
sleeve module which permit accurate fitting with hypodermic syringes or
cartridges; two handle supports; a housing support for the syringe; and,
a bellow or bulb section used to retract the sleeve in order to project
the needle and puncture the insertion point with the anesthesia or other
medicines.

7. The device of claim 5, the needle guide comprising: dimensions that
are proportional to the measurements of the sleeve module, thereby
allowing for the correct fitting of hypodermic syringes or cartridges.

8. A method of overcoming fear or anxiety in a patient during
administration of anesthesia or other medicine in a pediatric medical or
dental procedure comprising: covering a syringe and needle with the
device of claim 5 during the administration of the anesthesia or the
other medicine to the patient.

9. A method of overcoming fear and anxiety in a patient during
administration of anesthesia or other medicine in a pediatric medical or
dental procedure comprising: covering a syringe and needle with the
device of claim 6 during the administration of the anesthesia or the
other medicine to the patient.

10. A method of overcoming fear and anxiety in a patient during
administration of anesthesia or other medicine in a pediatric medical or
dental procedure comprising: covering a syringe and needle with the
device of claim 7 during the administration of the anesthesia or the
other medicine to the patient.

Description:

[0001] This patent application relates to a device for covering syringes
and needles for overcoming fear and anxiety in pediatric medical and
dental procedures during the administration of anesthesia and other
medicines, to be used especially by the pediatric dentist during the
execution of anesthesia procedures and by other health professionals for
injectable drug delivery, vaccinations, blood collection, etc.

[0002] Pain control through the overcoming of fear is one of the most
important aspects to encourage the pediatric patient to behave positively
in the dental clinic (Wilson, 1996; WALTER; FERELLI, ISSAO, 1999; ROULET,
GUEDES-PINTO, 2000).

[0003] However, the acceptance of treatment for this type of patient is
still a challenge for the dentist working with children, because the
administration of local anesthesia causes many children to avoid dental
consultation and treatment (JOHNSON; PRIMOSCH, 2003).

[0004] Because of this, aspects that relate to painful phenomena have
received special attention from professionals who specialize in child
development in the field of healthcare.

[0005] The method in dentistry most commonly used to avoid pain is the
inhibition of the channels that transmit nerve impulses through the
administration of local anesthetics near the nerve endings involved. The
local anesthetic prevents the depolarization of nerve fibers in the area
of absorption, preventing them from transmitting any nervous impulse
beyond that point (Bennett, 1989).

[0006] Local anesthesia is effective for dental procedures, but the
appearance of the anesthetic needle and syringe causes fear and anxiety
in many patients, particularly in pediatric dentistry.

[0007] Problems with patient management of children are often associated
with age, i.e. younger children of preschool age are more challenging,
and are compounded by the need for invasive medical procedures such as
anesthesia, restorations, pulpotomies, pulpectomies, surgery, etc.

[0008] In dentistry, these procedures often lead to the manifestation of
fear and of pain. Thus, the use of anesthetics, applied with syringes and
needles, is essential in most cases,.

[0009] Patients are afraid to go to the dental clinic because of the fear
of the application of anesthesia, specifically the syringe and needles
which cause pain, especially in the area of pediatric dentistry.

[0010] Pain control during pediatric dentistry is fundamentally important
not only to a successful treatment but also to the relationship between
the professional and the patient.

[0011] Local anesthetics aid treatment because they decrease the anxiety
and discomfort experienced by the young patient during restorative and
surgical procedures.

[0012] Therefore, certain aspects should be observed in pediatric
dentistry, such the psychological preparation of the patient, topical
anesthesia, pharmacological considerations of local anesthetics,
anesthetic techniques, local anesthetic toxicity, complications of local
anesthesia and new technologies related to local anesthesia.

[0013] The psychological preparation of the pediatric patient is
fundamental, because the child should cooperate with the dentist during
the application of the anesthetic in order to avoid any type of accident.
(YAP AUJ, ONG, G., 1996; ROULET PLBC, et al 1997; MCDONALD et al, 1998;
AZEVEDO AM et al, 2001).

[0014] The local anesthetic may be applied painlessly, depending on the
experience of the dentist and the collaboration of the patient.

[0015] Simply seeing a needle can initiate sensations of fear and anxiety
in the child, in some cases even resulting in a panic attack, making
dental treatment impossible. Therefore displaying the syringe and needle
is uncalled for in most cases.

[0016] The physiology of fear is set off from the moment that a child
enters into visual contact with objects that frighten the child. Upon
seeing such objects, the eyes send a stimulus to the brain, in the form
of electrical signals to the relevant structures that initiate a panic
reaction to the fear causing stimulus, which are the cerebral amygdalae,
located in the temporal lobes region.

[0017] The amygdalae send a signal to the hypothalamus, the area that
controls the metabolism, in order to intensify the production of
adrenalin, noradrenalin and acetylcholine.

[0018] Thus, in seconds, the release of these substances triggers several
changes in the individual's body, through the activation of the
sympathetic autonomic nervous system.

[0019] The type and intensity of physiological response and emotions vary,
but the organism can be fully mobilized and experience some of the
following systemic reactions due to panic:

[0020] a) Change in secondary blood flow, produced for the heart, muscles
and central nervous system so that the individual may have clear thinking
and quick action;

[0021] b) Liver: the release of sugar reserves by the liver
(gluconeogenesis) to supply the muscles;

[0024] e) Stomach may ache due to the increased production of
acetylcholine. There is increased release of gastric juices, speeding up
digestion and the transformation of food into energy (CORREA MSNP, 2002).

[0025] In pediatric dentistry, local anesthesia should always be
performed, even in the simplest procedures, such as the placement of a
brace during the performance of an isolate.

[0026] In practice, the methods currently used to try to minimize the
difficulties of treating children include only the use of a cartridge
syringe or placing a roll of cotton around the tip of the needle in an
attempt to distract the patient.

[0027] The recommended in dentistry practice is that the dentist should
try to move the syringe behind the child's head and below their line of
vision, when applying anesthesia to the oral cavity of the patient.

[0028] The other method of trying to hide a needle is to put a roll of
cotton around it. However, both of these maneuvers are inadequate,
because the child can see the syringe and the needle, whose shape will
frighten them. In addition there is a risk that the cotton may fall
during the procedure, frustrating the attempt to deceive the patient.

[0029] The image of the needle for the child patient is especially
traumatic, interfering with treatment in subsequent visits.

[0030] Another factor to be considered in relation to the image of the
needle is that fear can lead a child to move their head suddenly, causing
the needle already inserted in the oral mucosa to break, a complication
that could be avoided if the child does not make eye contact with the
needle.

[0031] Besides fear, children can also suffer from the feeling of anxiety.
The definition of anxiety refers to unease without cause or in relation
to any context of danger, and it has to do, in fact, with a unconscious
psychological cause (DE JONG, A 1988), in that most children's fears come
from the imagination.

[0032] The device for covering the syringe and needle to overcome fear and
anxiety in pediatric medical and dental procedures for the administration
of anesthesia and other medicines of the present application has been
developed to dispel fear and anxiety in children, especially of the
anesthetic syringe and needle used during dental treatment.

[0033] Currently, in the market and in practice, there is nothing that
administers a local anesthetic to the child effectively, safely and
painlessly, ensuring the positive response of the pediatric patient in
the dental office, avoiding fear, anxiety and discomfort to the patient
during restorative and surgical procedures.

[0034] To be successful in child patient management it is necessary to
connect with the child's world of imagination in order to establish a
trusting patient/professional relationship.

[0035] When a dental professional enters into the child's world by showing
them objects that are of interest, the patient is cooperative.

[0036] The experience of clinical pediatric dentistry at the University of
Uberaba has revealed that even before receiving its first dental
consultation, a child comes with a preconceived negative opinion
regarding dental treatment, due to remarks from their parents or other
adults, a fact that justified the research and development of the present
device.

[0037] For research purposes the device for covering syringes and needles
for overcoming fear and anxiety in pediatric medical and dental
procedures of the present invention was tested for two months at the
pediatric dentistry clinic of the University of Uberaba, with
approximately three hundred (300) children, producing evidence that the
children's acceptance of treatment improves when using the device,
optimizing their care and restoration of oral health.

[0038] When anesthetized using the device to overcome fear, the child
relates to his imaginary world because of its function and form,
facilitating a peaceful treatment free from anxiety and without fear,
because the objects of fear are out of the visual field.

[0039] Children who were anesthetized with the device for covering
syringes and needles for overcoming fear and anxiety in pediatric medical
and dental procedures of the present invention at the clinic of the
University of Uberaba no longer agree to be anesthetized with a standard
cartridge syringe and ask the professional to use the Device, because,
according to the patients, "it is better, because the tooth goes to sleep
without pain."

[0040] It can be seen that pain can be activated by suggestion and when
the child is fearful of an anesthetic syringe, they can withdraw, tense
their muscles, move their head and make treatment difficult or
impossible.

[0041] The device for covering syringes and needles for overcoming fear
and anxiety in pediatric medical and dental procedures of the present
invention is a great aid for the professional working with children,
disguising the shape of syringes used for injection.

[0042] The unique and inventive design of the Device is made by placing
both the syringe and the needle together into a sleeve to help overcome
fear and anxiety, transforming its appearance from the conventional
system of injection, which is easily recognized by patients, to a
creative and novel instrument.

[0043] The device for covering syringes and needles for overcoming fear
and anxiety in pediatric medical and dental procedures of the present
invention is characterized by a sleeve module for covering the syringe
and needle (1) and by a needle guide that prevents it from breaking
during anesthesia delivery (2).

[0044] When using the Device, the dentist or other health care
professional inserts the syringe (3) inside the lining of the syringe
sleeve module (4a and 4b), removes the needle cap and then places the
device inside the patient's oral cavity for the administration of
anesthesia, using pressure on the plunger (5) and the handles of the
supporting module which retracts the sleeve, exposing the needle (6).

[0045] The device can be fitted with hypodermic syringes or cartridges,
and at the front of the device there are two supporting handles (6), a
support housing for the syringe (7) and a bellowed or bulb section (8a or
8b) which enables the retraction of the device, the projection of the
needle and puncturing at the insertion point of anesthesia or other
medication.

[0046] A needle guide is located on the inside of the rear of the device
(2) in order to prevent the needle from breaking during anesthetic
injection, which can either be attached or pre-fabricated with the
module. The top of the device can also have a transparent version to
allow the dentist or other professional to verify the amount of
anesthesia or other medication being injected.

[0047] At the end of the injection, the dentist or other professional
releases pressure on the plunger and on the module's support handles and
the needle automatically retracts inside the device due to the expansion
of the bellows or bulb of the handle.

[0048] This device may be produced in polymer or other flexible materials
and in bright colors, promoting ecological associations by the use of
animal forms from nature such as the alligator, whale, eagle, hummingbird
and centipede, etc. (9a, 9b, 9c, 9d, 9e) or in the case of infants, a
feeding bottle (9f).

[0049] Therefore, the health professional can work more safely, free from
concerns related to potential trauma caused to patients resulting from
seeing the syringe and needle or by the fear of anesthesia.